Browse Device Recalls

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Nov 20, 2019 Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 18, 2019 STA UNICALIBRATOR (ref. 00675) A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX... Class II Diagnostica Stago, Inc.
Nov 18, 2019 STA SYSTEM CONROL N + P (ref. 00678) A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX... Class II Diagnostica Stago, Inc.
Nov 13, 2019 Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane... Sterile barrier system may be compromised Class II GETINGE US SALES LLC
Nov 7, 2019 Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless... May have a missing locking wire causing delay in surgery while retrieving a back-up device or imp... Class II Howmedica Osteonics Corp.
Nov 5, 2019 GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 -... The products may have been packaged with an incorrect Instructions for Use. Class II Collagen Matrix Inc
Nov 5, 2019 GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Prod... The products may have been packaged with an incorrect Instructions for Use. Class II Collagen Matrix Inc
Nov 5, 2019 GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Prod... The products may have been packaged with an incorrect Instructions for Use. Class II Collagen Matrix Inc
Nov 5, 2019 GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Prod... The products may have been packaged with an incorrect Instructions for Use. Class II Collagen Matrix Inc
Nov 5, 2019 GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 -... The products may have been packaged with an incorrect Instructions for Use. Class II Collagen Matrix Inc
Nov 5, 2019 GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 -... The products may have been packaged with an incorrect Instructions for Use. Class II Collagen Matrix Inc
Nov 4, 2019 Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of ... The indicator may show available charge when the battery is close to depletion. As a result, the ... Class II Becton Dickinson & Company
Nov 4, 2019 Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product... Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the packa... Class II Integra Lifesciences Sales Llc
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.